This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you.

“The alternative path is being marketed as a new fast-track path... that is obviously going to capture people’s attention. But is there anything new about it?” -Mike

“The new path puts a greater emphasis on technical standards... it’s similar to what we’ve been accustomed to many years.” -Jon

“This is exactly the abbreviated 510(k). There is absolutely nothing new here.” -Mike

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